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Trial record 2 of 380 for:    FERRIC CATION

ORal IrON Supplementation With Ferric Maltol in Patients With Heart Failure Carrying Left Ventricular Assist Devices (ORION-LVAD-1)

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ClinicalTrials.gov Identifier: NCT03774615
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
Shields, Shields and Associates
Information provided by (Responsible Party):
Hannover Medical School

Brief Summary:
This is a open-label, uncontrolled, monocenter, phase IV study. The aim of this study is to detect AEs or SAEs with a relative frequency of at least 11.5% in LVAD patients with iron deficiency anemia treated with oral ferric maltol for 12 weeks.

Condition or disease Intervention/treatment Phase
Heart Failure, Left Sided Anemia, Iron Deficiency Drug: Ferric maltol 30 mg (Feraccru®) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description: open-label, uncontrolled, monocenter, phase IV study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV Study to Explore the Safety of ORal IrON Supplementation With Ferric Maltol in Treating Iron Deficiency in Patients With Heart Failure Carrying Left Ventricular Assist Devices (ORION-LVAD-1)
Actual Study Start Date : March 18, 2019
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ferric maltol 30 mg (Feraccru®)
Treatment with Feraccru® 30 mg hard capsules (Ferric maltol 30 mg). One capsule twice daily, morning and evening, on an empty stomach for 12 weeks
Drug: Ferric maltol 30 mg (Feraccru®)
Feraccru® 30 mg hard capsules will be used. Each capsule contains 30 mg iron (as ferric maltol), 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110) as excipients with known effects




Primary Outcome Measures :
  1. To detect AEs and SAEs with a relative frequency of at least 11.5% in LVAD patients with iron deficiency anemia treated with oral ferric maltol for 12 weeks [ Time Frame: baseline to week 12 ]

Secondary Outcome Measures :
  1. Change in hemoglobin level from baseline to week 12 [ Time Frame: baseline to week 12 ]
  2. Change in hemoglobin level from baseline to week 6 [ Time Frame: baseline to week 6 ]
  3. Change in serum ferritin levels and transferrin saturation from baseline to week 6 [ Time Frame: baseline to week 6 ]
  4. Change in serum ferritin levels and transferrin saturation from baseline to week 12 [ Time Frame: baseline to week 12 ]
  5. Change in 6 min walking distance from baseline to week 12 [ Time Frame: baseline to week 12 ]
  6. Change in serum NT-proBNP from baseline to weeks 6 [ Time Frame: baseline to weeks 6 ]
  7. Change in serum NT-proBNP from baseline to weeks 12 [ Time Frame: baseline to weeks 12 ]
  8. Change in echocardiographic markers of right ventricular function (right atrial area, right ventricular diameter, fractional area change, tricuspid annular plane systolic excursion) [ Time Frame: change from baseline to week 12 ]
  9. Change in echocardiographic markers of left ventricular function (left ventricular ejection fraction, left atrial area, left ventricular diameter, fractional area change, tricuspid annular plane systolic excursion) [ Time Frame: change from baseline to week 12 ]
  10. Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 12 [ Time Frame: from baseline to week 12 ]
  11. Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 6 [ Time Frame: from baseline to week 6 ]
  12. Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 12 [ Time Frame: from baseline to week 12 ]
  13. Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 6 [ Time Frame: from baseline to week 6 ]
  14. Change in NYHA from baseline to week 12 [ Time Frame: from baseline to week 12 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed written informed consent prior to any study-related procedure and willingness to comply with treatment and follow-up procedures
  2. Male and female patients ≥18 years at day of inclusion
  3. Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial
  4. Patients that have an LVAD implanted for chronic heart failure and which are clinically stable for at least 6 months after LVAD implantation in the opinion of the investigator
  5. 6 min walk distance >50 m
  6. Mild-to-moderate iron-deficiency anemia as defined by a hemoglobin concentration ≥7 g/dl and <12 g/dl in females or ≥8 g/dl and <13 g/dl in males, and serum ferritin <100 µg/l, or 100-300 µg/l and transferrin saturation <20% at screening
  7. Women of childbearing potential must:

Have a negative pregnancy test at screening Agree to use reliable methods of contraception during the course of the study

Exclusion Criteria:

  1. Active hematological disorders other than iron-deficiency anemia
  2. Other medical condition that according to the investigator's assessment is causing or contributing to anemia
  3. Active malignancy
  4. Active infectious disease
  5. Active bleeding
  6. Severe renal insufficiency (requiring dialysis)
  7. Severe liver injury as indicated by serum aminotransferases >3 x upper limit of normal or bilirubin levels >50 µmol/l
  8. Ongoing oral or intravenous iron supplementation
  9. Concomitant erythropoietin medication
  10. Pregnancy or lactation period
  11. Subject has received any investigational medication or any investigational devices within 30 days prior to the first dose of study medication or is actively participating in any investigational drug/ devices trial, or is scheduled to receive investigational drug/devices during the course of the study.
  12. Known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal product
  13. Known haemochromatosis or other iron overload syndromes
  14. Patients who have been receiving repeated (>1) blood transfusions during the past 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774615


Contacts
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Contact: Jan Schmitto, Prof. MD +49 511 532 ext 3373 Schmitto.Jan@mh-hannover.de

Locations
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Germany
Medizinische Hochschule Hannover, Klinik für Herz-, Thorax-, Transplantations- und Gefäßchirurgie (HTTG) Recruiting
Hannover, Germany, 30625
Contact: Jan D. Schmitto, Prof. Dr. med.    +49 511 532 ext 3373    Schmitto.Jan@mh-hannover.de   
Sponsors and Collaborators
Hannover Medical School
Shields, Shields and Associates
Investigators
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Principal Investigator: Jan Schmitto, Prof. MD Hannover Medical School

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Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT03774615     History of Changes
Other Study ID Numbers: ORION-LVAD-1
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hannover Medical School:
Iron Deficiency
Additional relevant MeSH terms:
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Ferric maltol
Ferric Compounds
Heart Failure
Anemia, Iron-Deficiency
Heart Diseases
Cardiovascular Diseases
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Hematinics